NEUTRAL TOPICAL- sodium fluoride aerosol, foam

Neutral Topical by

Drug Labeling and Warnings

Neutral Topical by is a Prescription medication manufactured, distributed, or labeled by AMD Medicom Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

General Information

AMD Medicom Inc.

DentiCare Pro-Foam

2% Neutral Topical Sodium Fluoride Foam (0.9% fluoride ion)

Mint

4.4 oz / 125 g

NDC: 64778-0386-1

NPN 80009615

Rx Only in US

Item code 10038-M

I ndications and Directions

Indications: topical anti-caries preparation

Directions:

1. Following prophylaxis treatment, fill ¼ of tray with foam
2. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray
3. Insert tray in the patient’s mouth, have patient bite down lightly for 1 minute, up to a maximum of 4 minutes
4. Remove tray and have patient expectorate excess

Advise patient not to eat, drink or rinse for 30 minutes after the treatment

Medicinal ingredients: Fluoride ions 0.9% w/w (from 2% w/w sodium fluoride)

Non-Medicinal Ingredients

water, sucralose, xylitol, betaine, pluronic, peppermint oil, spearmint oil

Warnings

KEEP OUT OF REACH OF CHILDREN. For professional use only

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40°C or 104°F

Contents under pressure. Do not puncture or incinerate

Do not use if seal is broken

Contact Information

Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montreal, Quebec, Canada
H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

NEUTRAL TOPICAL 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0386
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-0386-3	12 in 1 CASE	12/01/2017
1	NDC: 64778-0386-1	125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2004

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)